FDA Adverse Event
Injury
Summary report: N
ASR UNI FEMORAL IMPL SIZE 49
MDR report key: 3112481
·
Received May 14, 2013
Report
- Report Number
- 1818910-2013-05452
- Event Type
- Injury
- Date Received
- May 14, 2013
- Date of Event
- March 24, 2015
- Report Date
- March 24, 2015
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- KWA
- PMA / PMN Number
- K040627
- Removal / Correction Number
- Z-1749/1816-2011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.
Additional Manufacturer Narrative · 1
DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED
Description of Event or Problem · 1
LITIGATION PAPERS ALLEGE WAS INJURED BY EXCESSIVE LEVELS OF CHROMIUM AND COBALT.
Description of Event or Problem · 1
UPDATE 24 MAR 2015: REC'D DER WITH FOLLOWING DETAILS: REVISION DATE CONFIRMED. REASON FOR REVISION: PAIN. PRODUCT STICKERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213431 | ASR UNI FEMORAL IMPL SIZE 49 | FEMORAL HEAD HIP IMPLANT | KWA | DEPUY INTERNATIONAL | 2249084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other| R |